Tear Osmolarity Changes After Instilling Isotonic Hyaluronate Artificial Tears

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas O Salmon, OD, PhD, Northeastern State University
ClinicalTrials.gov Identifier:
NCT01614847
First received: June 6, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

Background:

Osmolarity is defined as the concentration of particles dissolved in a solution. Normal tears contain various dissolved particles including proteins, salts and other electrolytes. The investigators plan to investigate how osmolarity of the tear film changes over time after instillation of artificial tears containing hyaluronate. This is one kind of artificial tear that is used to treat dry eye.

Dry eye and tear osmolarity:

Dry eye is a significant health problem, but diagnosis and treatment are often ambiguous and ineffective. There has been a resurgence of interest and research in dry eye in the past 5 years, and tear osmolarity has emerged as perhaps, one of the most effective ways to evaluate tear quality and dry eye status. Dry eye is usually treated with artificial tears, and many formulations are available. The investigators will test an isotonic solution that contains hyaluronate. Hyaluronate binds water and should help to maintain water on the eye.

Objective:

We plan to study the time course of possible changes in tear film osmolarity following instillation of an isotonic artificial tear containing hyaluronate. The investigators will use the TearLab, a new clinical instrument that has been developed to quickly and easily measure tear film osmolarity. Understanding how artificial tears affect tear film osmolarity over time can help doctors determine efficacy and dosing schedules. The investigators will test the isotonic hyaluronate (Blink Contacts) artificial tears relative to normal saline solution.

Hypothesis:

The investigators should be able to measure a decrease in tear osmolarity over time following instillation due to the water-binding effect of hyaluronate artificial tears relative to a control (normal saline solution).


Condition Intervention
Dry Eye
Drug: Artificial tears

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Tear Osmolarity Changes After Instilling Isotonic Hyaluronate Artificial Tears

Resource links provided by NLM:


Further study details as provided by Northeastern State University:

Primary Outcome Measures:
  • Osmolarity (mOsms/L) as a function of time (minutes) [ Time Frame: Approximately 1 hours post instillation ] [ Designated as safety issue: No ]
    Following instillation of artificial tears, we will collect a 50-nl sample of tears using the TearLab device, which will report osmolarity of the tear film. We will measure every 15 minutes following instillation, for up to 2 hours.


Enrollment: 8
Study Start Date: June 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypo-osmolar artificial tear
At random, subjects will receive hypo-osmolar artificial tear or a control (normal saline).
Drug: Artificial tears
At random, subjects will receive hypo-osmolar artificial tear or a control (normal saline).
Placebo Comparator: Normal saline Drug: Artificial tears
At random, subjects will receive hypo-osmolar artificial tear or a control (normal saline).

Detailed Description:

ABSTRACT:

Introduction: Tear hyper-osmolarity may be a fundamental cause of dry eye in many cases. Hyaluronate is an agent used in some artificial tears, which binds water and can protect against evaporation. It may therefore be an effective treatment for tear hyper-osmolarity.

Purpose: Our purpose was to measure changes in tear osmolarity over time following instillation of Blink Contacts, an isotonic ocular lubricant containing hyaluronate. We hypothesized that even in isotonic solution, the water-binding properties of hyaluronate would reduce tear osmolarity. This will help us better understand efficacy of this treatment and develop a rational basis for dosing schedules.

Methods: After baseline osmolarity measurements, eight subjects received either Blink Contacts or normal saline drops in both eyes. We re-measured osmolarity five minutes later, and then at 15-minute intervals up to 95 minutes. Subjects also rated comfort at each time. The next day, the experiment was repeated with the alternate drops for each subject.

Results: There was no statistically or clinically significant decrease in tear osmolarity over time for either Blink Contacts or normal saline, and there was no significant difference between the drops. Comfort ratings showed no significant difference at any time.

Conclusions: We conclude, although hyaluronate binds water, it does not significantly alter tear osmolarity when its osmolarity is similar to that of the tears. However, it may reduce osmolarity when it is more hypotonic relative to the tears. Small sample size, few eyes with hyperosmolarity and limitations of our methods may have affected results.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years of age Normal vision in both eyes (20/30 best corrected) Preference for patient with dry eye symptoms

Exclusion Criteria:

  • No ocular disease other than dry eye Currently taking no ocular or systemic medications that might affect results
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614847

Locations
United States, Oklahoma
Northeastern State University
Tahlequah, Oklahoma, United States, 74464
Sponsors and Collaborators
Thomas O Salmon, OD, PhD
  More Information

No publications provided

Responsible Party: Thomas O Salmon, OD, PhD, Professor, Northeastern State University
ClinicalTrials.gov Identifier: NCT01614847     History of Changes
Other Study ID Numbers: NSUOCO-2012-11
Study First Received: June 6, 2012
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northeastern State University:
dry eye
artificial tears
tear osmolarity
residence time

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014